Roche Pharmaceutical Development and Sales Overview
Tecentriq (atezolizumab, RG7446)
Anti-PD-L1 cancer immunotherapy - lung cancer
Indication
Phase/study
# of patients
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1L NSCLC
Cohort A: ALK+ (Alecensa)
Cohort B: RET+ (Alecensa)
Phase II/III
B-FAST
Modular design
Cohort C: bTMB-high (Tecentriq)
Stage IV NSCLC
Phase Ib/III
IMscin0011
N=371
☐
Design
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Cohort D: ROS1+ (Rozlytrek)
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Cohort E: BRAF+ (Zelboraf plus Cotellic plus Tecentriq)
Cohort F: EGFR Exon 20+ (Tecentriq, Avastin, carboplatin, pemetrexed)
Phase lb
Dose finding, Tecentriq SC followed by Tecentriq IV
Phase III
2L NSCLC non inferiority of Tecentriq SC vs Tecentriq IV
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Cohort G: GDC-6036 or Docetaxel
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Cohort A/B/D: Objective response rate
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Cohort C/G: Progression-free survival
Primary endpoint
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Cohort E: Time in response
Cohort F: Investigator-assessed objective response rate
FPI Q3 2017
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Recruitment completed for cohort A Q3 2018 and cohort C Q3 2019
Cohort A: primary endpoint met Q3 2019; approved in US Q1 2021
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Status
☐
Cohort C: did not show statistical significance for primary endpoint, data
presented at ESMO 2021
Cohort F: FPI Q2 2021
Observed concentration of Tecentriq in serum at cycle 1
FPI Q4 2018
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FPI in phase III part Q4 2020
Recruitment completed Q1 2022
Study met its primary end point Q3 2022
CT Identifier
¹SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase
NCT03178552
NCT03735121
ALK-Anaplastic lymphoma kinase; BRAF-V-raf murine sarcoma viral oncogene homolog B; bTMB-Blood-based tumor mutational burden; EGFR-Epidermal growth factor receptor; IV-intravenous; NSCLC-non-small cell lung
cancer; PD-L1=Programmed cell death-ligand 1; RET-Rearranged during transfection; ROS1-C-ros oncogene 1; SC-Subcutaneous, IV-Intravenous; ESMO-European Society for Medical Oncology
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Roche
OncologyView entire presentation